{"id":30260,"date":"2021-12-19T15:31:42","date_gmt":"2021-12-19T14:31:42","guid":{"rendered":"https:\/\/nh-oring.de\/fda-approval\/"},"modified":"2025-05-07T09:18:39","modified_gmt":"2025-05-07T07:18:39","slug":"fda-approval","status":"publish","type":"post","link":"https:\/\/nh-oring.de\/en\/fda-approval\/","title":{"rendered":"FDA approval"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"30260\" class=\"elementor elementor-30260 elementor-28286\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-71bd018 elementor-section-height-min-height elementor-section-boxed elementor-section-height-default elementor-section-items-middle\" data-id=\"71bd018\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-433e23c\" data-id=\"433e23c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e6f4c5a elementor-widget elementor-widget-heading\" data-id=\"e6f4c5a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\"><span style=\"font-family: var( --e-global-typography-primary-font-family ), Sans-serif\">FDA approval<\/span><\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b278a5 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"8b278a5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-75983e9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"75983e9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-256409c\" data-id=\"256409c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5db4681 elementor-widget elementor-widget-spacer\" data-id=\"5db4681\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2d899ca elementor-widget elementor-widget-heading\" data-id=\"2d899ca\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FDA approval: Everything you need to know<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4480a06 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"4480a06\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6fe3e40 elementor-widget elementor-widget-text-editor\" data-id=\"6fe3e40\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Food and Drug Administration (FDA) is a US authority responsible for monitoring and regulating food, drugs, medical devices, tobacco products and cosmetics.  <\/p><p>Its main task is to protect public health by ensuring that these products are safe, effective and correctly labeled. This includes both domestic and imported products.   <\/p><p>The FDA was founded in 1927, and its role has evolved over time, particularly in response to various medical crises and scandals.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2e88bc7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2e88bc7\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d7251e7\" data-id=\"d7251e7\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1a1505c elementor-widget elementor-widget-heading\" data-id=\"1a1505c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">REQUEST O-RINGS QUICKLY AND EASILY?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ccf1040 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ccf1040\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6944097 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6944097\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-0027ab4\" data-id=\"0027ab4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ad23158 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"ad23158\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"far fa-check-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-6edce78\" data-id=\"6edce78\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-57deb92 elementor-widget elementor-widget-text-editor\" data-id=\"57deb92\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Almost any dimension available<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-4599fef elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4599fef\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-fa055fd\" data-id=\"fa055fd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ff0fce8 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"ff0fce8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"far fa-check-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-c829f19\" data-id=\"c829f19\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-282c663 elementor-widget elementor-widget-text-editor\" data-id=\"282c663\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Offer received in record time<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-ba6160b elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ba6160b\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-ca3546b\" data-id=\"ca3546b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-97563fc elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"97563fc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"far fa-check-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-5aaf4d6\" data-id=\"5aaf4d6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-21eddd2 elementor-widget elementor-widget-text-editor\" data-id=\"21eddd2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>No minimum order quantities or minimum item values<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-98dda3c elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"98dda3c\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-ee9a88a\" data-id=\"ee9a88a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a382b9a elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"a382b9a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"far fa-check-circle\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-96c76bb\" data-id=\"96c76bb\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-49ab16f elementor-widget elementor-widget-text-editor\" data-id=\"49ab16f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>One contact for all concerns<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-bf7428c elementor-align-center elementor-widget elementor-widget-button\" data-id=\"bf7428c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/nh-oring.de\/en\/o-rings\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t<span class=\"elementor-button-icon\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"far fa-arrow-alt-circle-right\"><\/i>\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">REQUEST O-RINGS HERE<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0edd110 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0edd110\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-5efd3fd\" data-id=\"5efd3fd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-7af0685 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7af0685\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-bab5953\" data-id=\"bab5953\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a692c8c elementor-widget elementor-widget-heading\" data-id=\"a692c8c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><a href=\"#1\">TABLE OF CONTENTS<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af82fd6 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"af82fd6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-fa1157e elementor-widget elementor-widget-heading\" data-id=\"fa1157e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><a href=\"#1\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 4px\">#1<\/span> FDA approval: Basics<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f009bf4 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f009bf4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-715ba4f elementor-widget elementor-widget-heading\" data-id=\"715ba4f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><a href=\"#2\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 4px\">#2<\/span> FDA approval: The approval process<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78105bf elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"78105bf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e31d6a elementor-widget elementor-widget-heading\" data-id=\"5e31d6a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><a href=\"#3\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 4px\">#3<\/span> FDA approval: challenges and hurdles<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f2965fa elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"f2965fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-89cf624 elementor-widget elementor-widget-heading\" data-id=\"89cf624\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><a href=\"#4\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 4px\">#4<\/span> FDA approval: Elastomers and Code of Federal Regulations (CFR)<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a8de4ba elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"a8de4ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a661150 elementor-widget elementor-widget-heading\" data-id=\"a661150\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><a href=\"#5\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 4px\">#5<\/span> FDA approval: future and conclusion<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75390a1 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"75390a1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45816fb elementor-widget elementor-widget-heading\" data-id=\"45816fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-heading-title elementor-size-default\"><a href=\"#6\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 4px\">#6<\/span> FDA approval: Further questions answered<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ae3719a elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"ae3719a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-9e63d7d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"9e63d7d\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-f32c456\" data-id=\"f32c456\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-731b603 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"731b603\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-58c44db\" data-id=\"58c44db\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-296b000 elementor-widget elementor-widget-spacer\" data-id=\"296b000\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1071fa elementor-widget elementor-widget-heading\" data-id=\"a1071fa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#1<\/span> FDA approval: Basics<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b91ec46 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"b91ec46\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-05c9823 elementor-widget elementor-widget-text-editor\" data-id=\"05c9823\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>FDA approval is a crucial step for the introduction of new drugs and medical devices to the US market.  <\/p><p>It ensures that these products meet the authority&#8217;s strict safety and efficacy standards. The approval is based on a comprehensive review of the documentation submitted by the manufacturers, which must prove the quality, efficacy and safety of the products.   <\/p><p>This includes conducting and evaluating clinical studies, manufacturing according to defined standards and providing detailed information on the composition and mode of action of the product.<\/p><p>The FDA structure includes various centers and offices that specialize in specific product categories, such as the Center for Drug Evaluation and Research and the Center for Food Safety and Applied Nutrition.  <\/p><p>This structure enables the FDA to respond effectively to the specific challenges and requirements of each product category.<\/p><p>The FDA approval process is known worldwide for its rigor and detail. FDA approval is often considered the gold standard in the pharmaceutical industry as it signals a high level of confidence in the safety and efficacy of a product. The FDA&#8217;s decisions often influence regulatory practices in other countries.  <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f0c92e9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f0c92e9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-534ed74\" data-id=\"534ed74\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-5e09c5f elementor-widget elementor-widget-image\" data-id=\"5e09c5f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"403\" src=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-2-1024x403.png\" class=\"attachment-large size-large wp-image-28317\" alt=\"FDA Zulassung Logo\" srcset=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-2-1024x403.png 1024w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-2-300x118.png 300w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-2-768x302.png 768w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-2.png 1226w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-77d6c0f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"77d6c0f\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-d7e38ff\" data-id=\"d7e38ff\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7210eda elementor-widget elementor-widget-spacer\" data-id=\"7210eda\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c5d9eec elementor-widget elementor-widget-heading\" data-id=\"c5d9eec\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#2<\/span> FDA approval: The approval process<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-442fe5e elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"442fe5e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1a33e73 elementor-widget elementor-widget-text-editor\" data-id=\"1a33e73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The Food and Drug Administration (FDA) approval process is a complex, multi-step process designed to ensure the safety and efficacy of medical devices and drugs before they are approved for the U.S. market.<\/p><h3>Main approval procedure for medical devices<\/h3><p>The FDA has various approval processes for medical devices, including:<\/p><ol><li><strong>Premarket Notification 510(k) (PMN)<\/strong>: For products that are substantially equivalent to an existing and approved product.<\/li><li><strong>Premarket Approval (PMA)<\/strong>: This is the most stringent procedure required for Class III medical devices. It involves an in-depth review of safety and efficacy by the FDA. <\/li><li><strong>Investigational Device Exemption (IDE)<\/strong>: Allows the use of an investigational device in clinical trials.<\/li><li><strong>Humanitarian Device Exemption (HDE)<\/strong>: For devices intended for the treatment or diagnosis of rare diseases or conditions.<\/li><\/ol><h3>Phases of the drug approval procedure<\/h3><p>The authorization procedure for medicinal products comprises several phases:<\/p><p><strong style=\"color: var( --e-global-color-text );\">Phase 1<\/strong><span style=\"color: var( --e-global-color-text );\">Focuses on safety, involves 20 to 80 healthy volunteers and lasts about a year.<\/span><\/p><p><strong style=\"color: var( --e-global-color-text );\">Phase 2<\/strong><span style=\"color: var( --e-global-color-text );\">Focuses on efficacy. In this phase, approximately 100 to 300 patients are observed over a period of two years. <\/span><\/p><p><strong style=\"color: var( --e-global-color-text );\">Phase 3<\/strong><span style=\"color: var( --e-global-color-text );\">Phase 2 : Begins when proof of efficacy has been provided in phase 2. It comprises several hundred to 3,000 patients and lasts an average of three years. <\/span><\/p><p><strong style=\"color: var( --e-global-color-text );\">Phase 4<\/strong><span style=\"color: var( --e-global-color-text );\">Post-market surveillance for further evaluation of safety and efficacy after approval.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5daa017 elementor-widget elementor-widget-image\" data-id=\"5daa017\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1024\" height=\"522\" src=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/12\/FDA-1024x522.png\" class=\"attachment-large size-large wp-image-30052\" alt=\"FDA Darstellung\" srcset=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/12\/FDA-1024x522.png 1024w, https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/12\/FDA-300x153.png 300w, https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/12\/FDA-768x392.png 768w, https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/12\/FDA-1536x783.png 1536w, https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/12\/FDA-2048x1045.png 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-68b181e elementor-widget elementor-widget-text-editor\" data-id=\"68b181e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-size: 22px; font-style: inherit; font-weight: bold; color: var( --e-global-color-text );\">New Drug Application (NDA)<\/span><\/p><p>The submission of a New Drug Application (NDA) is a crucial step in which the manufacturer asks the FDA for permission to market its drug on the US market. This application includes extensive data from animal studies and clinical trials as well as information on dosage, side effects and pharmacokinetics. <\/p><h3>Special approval programs<\/h3><p>The FDA also has special programs to expedite the development and review of certain drugs:<\/p><ul><li><strong>Fast Track<\/strong>: For drugs that treat serious illnesses and fulfill an unmet medical need.<\/li><li><strong>Breakthrough Therapy<\/strong>: For drugs that show a significant improvement over existing treatments.<\/li><li><strong>Priority review<\/strong>: The aim is to decide on an application within six months.<\/li><li><strong>Accelerated Approval<\/strong>: Can be used for promising therapies that treat a serious or life-threatening condition.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-0c9636a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0c9636a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-b455db4\" data-id=\"b455db4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-200c3b3 elementor-widget elementor-widget-image\" data-id=\"200c3b3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1024\" height=\"403\" src=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-3-1024x403.png\" class=\"attachment-large size-large wp-image-28319\" alt=\"FDA Sign\" srcset=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-3-1024x403.png 1024w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-3-300x118.png 300w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-3-768x302.png 768w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-3.png 1226w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-97ba720 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"97ba720\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-811a7c6\" data-id=\"811a7c6\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-7f337ad elementor-widget elementor-widget-spacer\" data-id=\"7f337ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e55eac elementor-widget elementor-widget-heading\" data-id=\"9e55eac\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#3<\/span> FDA approval: challenges and hurdles<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b7ad50a elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"b7ad50a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-48ac08c elementor-widget elementor-widget-text-editor\" data-id=\"48ac08c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/www.fda.gov\/drugs\/how-drugs-are-developed-and-approved\/types-applications\" target=\"_blank\" rel=\"noopener\">Food and Drug Administration (FDA)<\/a><\/span> offers various types of approvals for drugs, biological products and medical devices. Common application types include: <\/p><p><span style=\"color: var( --e-global-color-text );\"><b>New Drug Application (NDA)<br><\/b><\/span><span style=\"color: var( --e-global-color-text );\">This application is submitted when a company believes it has gathered sufficient evidence of a new drug&#8217;s safety and effectiveness to meet the FDA&#8217;s requirements for marketing approval. The NDA must include data from a variety of technical perspectives, including chemistry, pharmacology, medicine, biopharmaceutics and statistics. <\/span><\/p><p><strong style=\"color: var( --e-global-color-text );\">Abbreviated New Drug Application (ANDA)<br><\/strong><span style=\"color: var( --e-global-color-text );\">This application allows for the review and ultimate approval of a generic drug. Generic drug applications are referred to as &#8220;abbreviated&#8221; because they typically do not need to include preclinical (animal) and clinical (human) data on safety and efficacy. Instead, the applicant must scientifically demonstrate that their product is bioequivalent (i.e. it works in the same way as the innovator drug).  <\/span><\/p><p><strong style=\"color: var( --e-global-color-text );\">Investigational New Drug Application <\/strong><span style=\"font-weight: bold; color: var( --e-global-color-text );\">(IND)<\/span><strong style=\"color: var( --e-global-color-text );\"><br><\/strong><span style=\"color: var( --e-global-color-text );\">This is required to obtain an exemption from the statutory requirement that a drug must undergo an approved marketing application before it is transported or distributed across state lines.<\/span><\/p><p><strong style=\"color: var( --e-global-color-text );\">Biologics License Application (BLA)<br><\/strong><span style=\"color: var( --e-global-color-text );\">Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. A BLA contains specific information about the manufacturing processes, chemistry, pharmacology, clinical pharmacology, and medical effects of the biological product. <\/span><\/p><p><strong style=\"color: var( --e-global-color-text );\">Over-the-Counter Drugs (OTC)<br><\/strong><span style=\"color: var( --e-global-color-text );\">OTC medicines can be approved either through an NDA or an OTC monograph procedure. An OTC monograph procedure is essentially a &#8220;rule book&#8221; for each therapeutic category that establishes conditions such as active ingredients, uses (indications), dosages, labeling and testing under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without an NDA and prior FDA approval. <\/span><\/p><p>The approval process for medical devices is similar to that for medicinal products. These devices are classified according to risk, with Class I being the lowest and Class III the highest risk level. <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-17598fd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"17598fd\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-5e94ec0\" data-id=\"5e94ec0\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-17823eb elementor-widget elementor-widget-image\" data-id=\"17823eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"403\" src=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-4-1024x403.png\" class=\"attachment-large size-large wp-image-28321\" alt=\"FDA Medizin\" srcset=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-4-1024x403.png 1024w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-4-300x118.png 300w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-4-768x302.png 768w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/FDA-4.png 1226w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-1a58c0a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1a58c0a\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-c685939\" data-id=\"c685939\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1820656 elementor-widget elementor-widget-spacer\" data-id=\"1820656\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6568877 elementor-widget elementor-widget-heading\" data-id=\"6568877\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#4<\/span> FDA approval: Elastomers and Code of Federal Regulations (CFR)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9ac0adc elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"9ac0adc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-208d5bb elementor-widget elementor-widget-text-editor\" data-id=\"208d5bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The provisions of the <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/www.mnrubber.com\/\" target=\"_blank\" rel=\"noopener\">CFR (Code of Federal Regulations)<\/a><\/span> Title 21 focuses in particular on the regulations relating to elastomers and rubber in the food, beverage and water sectors.<\/p><p><strong>CFR Title 21 and elastomers\/rubber<\/strong><\/p><p>FDA regulations for rubber products that come into contact with food are set forth in CFR Title 21, Chapter 1, Subchapter B, Part 177, Subpart C and Section 2600. These regulations provide guidance on the manufacture and use of elastomers and rubber in products used in the food and beverage industry. <\/p><p>The FDA divides food into two categories when it comes to compatibility with rubber:<\/p><p><strong>Class I<\/strong>: This category includes foods such as edible oils, butter, milk and dairy products as well as cooking oils. Rubber compounds that meet these requirements are also compatible with Class II foods. <\/p><p><strong>Class II<\/strong>: This category refers to foods that do not contain edible oils or dairy products, such as water, soft drinks, alcoholic beverages and other aqueous solutions.<\/p><p><strong>FDA 21 CFR 177.2600<\/strong><\/p><p>The 21 CFR 177.2600 regulation is essentially a list of approved base elastomers and vulcanization materials.  <\/p><p>These materials are used in rubber production and are considered safe. Products that comply with these guidelines are used in applications such as gaskets, worktops, non-slip pads and shielding in food processing.   <\/p><p>They are also found in butchers, pharmaceutical processing plants, commercial kitchens, hospitals, food processing plants, the cosmetics industry, industrial plants and grocery stores.<\/p><p>Common <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/o-rings\/\" target=\"_blank\" rel=\"noopener\">O-ring<\/a><\/span> materials with FDA approval are <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/ffkm-o-rings-materials-simply-explained\/\" target=\"_blank\" rel=\"noopener\">FFKM<\/a><\/span>, <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/epdm-o-ringe-3\/\" target=\"_blank\" rel=\"noopener\">EPDM<\/a><\/span>,     <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/fkm-o-rings-materials-simply-explained\/\" target=\"_blank\" rel=\"noopener\">FKM<\/a><\/span>, <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/ptfe-o-rings-materials-simply-explained\/\" target=\"_blank\" rel=\"noopener\">PTFE<\/a><\/span>, <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/fep-o-rings-materials-simply-explained\/\" target=\"_blank\" rel=\"noopener\">FEP<\/a><\/span>, <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/silikon-o-rings-materials-simply-explained\/\" target=\"_blank\" rel=\"noopener\">VMQ<\/a><\/span> AND <span style=\"color: #fe5050;\"><a style=\"color: #fe5050;\" href=\"https:\/\/nh-oring.de\/en\/fvmq-o-rings-materials-simply-explained\/\" target=\"_blank\" rel=\"noopener\">FVMQ<\/a><\/span>.<\/p><p> <\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a508d22 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a508d22\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-fea4679\" data-id=\"fea4679\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c9397f2 elementor-widget elementor-widget-image\" data-id=\"c9397f2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"407\" src=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/Nahaufnahme-NBR-O-Ring-1024x407.png\" class=\"attachment-large size-large wp-image-28139\" alt=\"O-Ringe Nahaufnahme\" srcset=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/Nahaufnahme-NBR-O-Ring-1024x407.png 1024w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/Nahaufnahme-NBR-O-Ring-300x119.png 300w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/Nahaufnahme-NBR-O-Ring-768x305.png 768w, https:\/\/nh-oring.de\/wp-content\/uploads\/2023\/12\/Nahaufnahme-NBR-O-Ring.png 1219w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-af855f3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"af855f3\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-b8241bb\" data-id=\"b8241bb\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-3558844 elementor-widget elementor-widget-spacer\" data-id=\"3558844\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e63018d elementor-widget elementor-widget-heading\" data-id=\"e63018d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#5<\/span> FDA approval: future and conclusion<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-57423b0 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"57423b0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-39166f1 elementor-widget elementor-widget-text-editor\" data-id=\"39166f1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The future of the FDA approval process looks set for some important developments:<\/p><p><span style=\"color: var( --e-global-color-text );\"><b>Improved processes for drug approval and monitoring<br><\/b><\/span><span style=\"color: var( --e-global-color-text );\">The FDA has improved its drug approval processes, helping to ensure that patients have faster access to effective medications while minimizing the risk of drug side effects.<\/span><\/p><p><span style=\"color: var( --e-global-color-text );\"><b>New laws to improve the approval process<br><\/b><\/span><span style=\"color: var( --e-global-color-text );\">Laws such as the FDA Safety and Innovation Act (FDASIA) of 2013 were enacted to improve the approval process and expand access to new drugs.<\/span><\/p><p><span style=\"color: var( --e-global-color-text );\"><b>Increased efficiency and cost reduction<br><\/b><\/span><span style=\"color: var( --e-global-color-text );\">By shortening the median approval time for new molecular drugs from 19 to 10 months and introducing new laws, the FDA aims to make the process more efficient<\/span><\/p><p><span style=\"color: var( --e-global-color-text );\"><b>Continuous improvement and collaboration<br><\/b><\/span><span style=\"color: var( --e-global-color-text );\">The FDA strives to continuously improve its processes and collaborates with various organizations to develop safe and effective medicines for patients.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a60a3b9 elementor-widget elementor-widget-spacer\" data-id=\"a60a3b9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2dc4996 elementor-widget elementor-widget-heading\" data-id=\"2dc4996\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#6<\/span> FDA approval: More questions answered<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c7fe689 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"c7fe689\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c725305 elementor-widget elementor-widget-text-editor\" data-id=\"c725305\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>In the following chapter we will answer further questions on the subject of FDA approval.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0815e21 elementor-widget elementor-widget-heading\" data-id=\"0815e21\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#6.1<\/span> FDA approval for medical devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<div class=\"elementor-element elementor-element-3b1c73e elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"3b1c73e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1795664 elementor-widget elementor-widget-text-editor\" data-id=\"1795664\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>FDA approval is crucial for the safety and efficacy of medical devices.  <\/p><p>It guarantees that products have undergone rigorous testing before being placed on the market, which is important for patients and manufacturers alike.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b92aff2 elementor-widget elementor-widget-heading\" data-id=\"b92aff2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\"><span style=\"background-color:#fe5050;color: #ffffff;padding: 3px\">#6.2<\/span> FDA approval in Germany<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-574e87f elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"574e87f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-157d15f elementor-widget elementor-widget-text-editor\" data-id=\"157d15f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>FDA approval also plays an important role in Germany, especially for companies that want to launch their medical devices and drugs on the US market.  <\/p><p>It symbolizes high safety and quality standards, which strengthens confidence in these products.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-69c4080 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"69c4080\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-85f525b\" data-id=\"85f525b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-eed9760 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"eed9760\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-370da6b\" data-id=\"370da6b\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4f3df32 elementor-widget elementor-widget-text-editor\" data-id=\"4f3df32\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>&#8220;I am convinced that we should share our knowledge with the world. I hope I have been able to answer all your questions. If you have any further questions, please feel free to contact us at any time. We will be happy to help you.&#8221;<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a4b67fb elementor-author-box--layout-image-above elementor-author-box--align-center elementor-widget elementor-widget-author-box\" data-id=\"a4b67fb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/01\/Luke_zuschnitt-300x300.jpg\" alt=\"Picture of Luke Williams\" loading=\"lazy\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\t\t\t\t\t<div >\n\t\t\t\t\t\t<div class=\"elementor-author-box__name\">\n\t\t\t\t\t\t\tLuke Williams\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-author-box__bio\">\n\t\t\t\t\t\t<p>Lord of the O-rings<br \/>\nAuthor of the Sealing Academy<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-55c58fe elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"55c58fe\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-07e0f8a\" data-id=\"07e0f8a\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-908bab8 elementor-widget elementor-widget-heading\" data-id=\"908bab8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">OUR O-RING BESTSELLERS<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bb01985 elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"bb01985\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-e78e2d9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e78e2d9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-22b2faf\" data-id=\"22b2faf\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b5463ce elementor-cta--layout-image-above elementor-cta--valign-middle elementor-cta--skin-classic elementor-animated-content elementor-widget elementor-widget-call-to-action\" data-id=\"b5463ce\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"call-to-action.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<a class=\"elementor-cta\" href=\"https:\/\/nh-oring.de\/en\/ffkm-o-rings-materials-simply-explained\/\">\n\t\t\t\t\t<div class=\"elementor-cta__bg-wrapper\">\n\t\t\t\t<div class=\"elementor-cta__bg elementor-bg\" style=\"background-image: url(https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/01\/FKM-O-Ringe-300-x-200.png);\" role=\"img\" aria-label=\"O-Ringe schwarz\"><\/div>\n\t\t\t\t<div class=\"elementor-cta__bg-overlay\"><\/div>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-cta__content\">\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-cta__title elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t\tFFKM\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-ribbon elementor-ribbon-right\">\n\t\t\t\t<div class=\"elementor-ribbon-inner\">\n\t\t\t\t\tECOLAST\u00ae\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-e75cd0e\" data-id=\"e75cd0e\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-78dbc65 elementor-cta--layout-image-above elementor-cta--valign-middle elementor-cta--skin-classic elementor-animated-content elementor-widget elementor-widget-call-to-action\" data-id=\"78dbc65\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"call-to-action.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<a class=\"elementor-cta\" href=\"https:\/\/nh-oring.de\/en\/fkm-o-rings-materials-simply-explained\/\">\n\t\t\t\t\t<div class=\"elementor-cta__bg-wrapper\">\n\t\t\t\t<div class=\"elementor-cta__bg elementor-bg\" style=\"background-image: url(https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/01\/FKM-O-Ringe-300-x-200.png);\" role=\"img\" aria-label=\"O-Ringe schwarz\"><\/div>\n\t\t\t\t<div class=\"elementor-cta__bg-overlay\"><\/div>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-cta__content\">\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-cta__title elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t\tFKM\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-33 elementor-inner-column elementor-element elementor-element-424925b\" data-id=\"424925b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1d8c484 elementor-cta--layout-image-above elementor-cta--valign-middle elementor-cta--skin-classic elementor-animated-content elementor-widget elementor-widget-call-to-action\" data-id=\"1d8c484\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"call-to-action.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<a class=\"elementor-cta\" href=\"https:\/\/nh-oring.de\/en\/fep-o-rings-materials-simply-explained\/\">\n\t\t\t\t\t<div class=\"elementor-cta__bg-wrapper\">\n\t\t\t\t<div class=\"elementor-cta__bg elementor-bg\" style=\"background-image: url(https:\/\/nh-oring.de\/wp-content\/uploads\/2021\/01\/FEP-PFA-O-Ringe-300-x-200.png);\" role=\"img\" aria-label=\"FEP ummantelte O-Ringe\"><\/div>\n\t\t\t\t<div class=\"elementor-cta__bg-overlay\"><\/div>\n\t\t\t<\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-cta__content\">\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<h3 class=\"elementor-cta__title elementor-cta__content-item elementor-content-item\">\n\t\t\t\t\t\tFEP\/PFA\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>FDA approval: a guarantee for drug safety and efficacy. Indispensable in the healthcare industry. <\/p>\n","protected":false},"author":1,"featured_media":28289,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":{"footnotes":""},"categories":[68],"tags":[],"class_list":["post-30260","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-materials"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA approval | Sealing Academy NH O-RING<\/title>\n<meta name=\"description\" content=\"Discover our article on the topic of FDA approval \u2705 Origin \u2705 Guidelines \u2705 Test procedure \u2705 Application examples \u2705 Click here!\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nh-oring.de\/en\/fda-approval\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA approval | Sealing Academy NH O-RING\" \/>\n<meta property=\"og:description\" content=\"Discover our article on the topic of FDA approval \u2705 Origin \u2705 Guidelines \u2705 Test procedure \u2705 Application examples \u2705 Click here!\" \/>\n<meta property=\"og:url\" content=\"https:\/\/nh-oring.de\/en\/fda-approval\/\" \/>\n<meta property=\"og:site_name\" content=\"NH O-RING - 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